Did you know DFE Pharma is the first to offer nitrite values as standard on Certificates of Analyses for our key lactose grades? For over 125 years, DFE Pharma has been a trusted partner to the world’s leading pharmaceutical companies — and our lactose excipient portfolio continues to set the industry benchmark.
Transparent data, reliable results
Every batch of our key lactose grades comes with a CoA that includes detailed nitrite values for easy tracking, empowering you to make informed decision and mitigate nitrosamine risks.
Regulatory confidence
Our proactive approach supports compliance with global regulatory requirements now and into the future, giving you peace of mind through development and production phases.
DFE Pharma continues to set new standards for quality and transparency.
- Leading levels of quantification: reporting limit of 0.03ppm1
- Controlled processes allowing leading low nitrite levels:
- Typical values <0.03ppm
- Controlled processes allowing leading low nitrite levels:
Our experience goes beyond tradition — it powers forward-thinking solutions, including in-house model drug formulations tailored to real-world API challenges.
Stay ahead of the curve. Learn more about DFE Pharma’s lactose portfolio.